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(acetylcholine chloride intraocular solution) 20 mg/2 mL (10 mg/mL) Sterile
1:100 with Electrolyte Diluent Rx only
FOR INTRAOCULAR USE ONLY
Miochol-E (acetylcholine chloride intraocular solution) is a parasympathomimetic preparation for intraocular use. It is packaged in a blister pack containing one vial and one diluent ampule. The vial contains 20 mg acetylcholine chloride and 56 mg mannitol. The accompanying ampule contains 2 mL of a modified diluent of calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate, and sterile water for injection.
The reconstituted liquid will be a sterile isotonic solution (275–330 milliosmoles/kg) containing 20 mg acetylcholine chloride (1:100 solution) and 2.8% mannitol. The pH range is 5.0–8.2. Mannitol is used in the process of lyophilizing acetylcholine chloride, and is not considered an active ingredient.
The chemical name for acetylcholine chloride, CHClNO, is Ethanaminium, 2-(acetyloxy)-N,N,N-trimethyl-, chloride and is represented by the following chemical structure:
Acetylcholine is a naturally occurring neurohormone which mediates nerve impulse transmission at all cholinergic sites involving somatic and autonomic nerves. After release from the nerve ending, acetylcholine is rapidly inactivated by the enzyme acetylcholinesterase by hydrolysis to acetic acid and choline.
Direct application of acetylcholine to the iris will cause rapid miosis of short duration. Topical ocular instillation of acetylcholine to the intact eye causes no discernible response as cholinesterase destroys the molecule more rapidly than it can penetrate the cornea.
To obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis may be required.
Miochol-E is contraindicated in persons with a known hypersensitivity to any component of this product.
DO NOT GAS STERILIZE. If blister or peelable backing is damaged or broken, sterility of the enclosed vial and ampule cannot be assured. Open under aseptic conditions only.
If miosis is to be obtained quickly with Miochol-E, anatomical hindrances to miosis, such as anterior or posterior synechiae, must be released, prior to administration of Miochol-E. During cataract surgery, use Miochol-E only after delivery of the lens.
Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution which is not clear and colorless. Discard any solution that has not been used.
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with topical nonsteroidal anti-inflammatory agents.
Safety and effectiveness in pediatric patients have not been established.
Infrequent cases of corneal edema, corneal clouding, and corneal decompensation have been reported with the use of intraocular acetylcholine.
Adverse reactions have been reported rarely, which are indicative of systemic absorption. These include bradycardia, hypotension, flushing, breathing difficulties, and sweating.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Atropine sulfate (0.5 to 1 mg) should be given intramuscularly or intravenously and should be readily available to counteract possible overdosage. Epinephrine (0.1 to 1 mg subcutaneously) is also of value in overcoming severe cardiovascular or bronchoconstrictor responses.
Miochol-E (acetylcholine chloride intraocular solution) is instilled into the anterior chamber before or after securing one or more sutures.
Instillation should be gentle and parallel to the iris face and tangential to pupil border.
If there are no mechanical hindrances, the pupil starts to constrict in seconds and the peripheral iris is drawn away from the angle of the anterior chamber. Any anatomical hindrance to miosis must be released to permit the desired effect of the drug. In most cases, 0.5 to 2 mL produces satisfactory miosis. Note that the syringe filter supplied with Miochol-E has a priming volume of 0.6 mL (approximately).
In cataract surgery, use Miochol-E only after delivery of the lens.
Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution that is not clear and colorless. Discard any solution that has not been used.
STERILE UNLESS PACKAGE OPEN OR BROKEN
Discard the filter appropriately after use.
Do not reuse the syringe filter.
Do not aspirate and inject through the same filter.
Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20
One blister pack containing the following components:
One 0.2 micron sterile filter
Store at 4°-25°C (39°-77°F)
KEEP FROM FREEZING
KEEP OUT OF REACH OF CHILDREN
Manufactured for: Bausch + Lomb, a division ofValeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA
Manufactured by: Sanofi S.p.A.Via Valcanello, 403012 ANAGNI (FR)
Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.
©Bausch & Lomb Incorporated
Miochol-E (acetylcholine chloride intraocular solution)
20 mg/2 mL (10 mg/mL)
1:100 with Electrolyte Diluent
FOR INTRAOCULAR USE ONLY
Contents: One Blister Pack containing: -20mg vial -2 mL diluent ampuleOne 0.2 micron sterile filter
BAUSCH + LOMB
Bausch & Lomb Incorporated
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